Applied regulatory science research to evaluate and treat cardiotoxicity of oncology therapeutics

The U.S. Department of Health and Human Services, through the Food and Drug Administration (FDA), has announced a forecasted funding opportunity entitled Applied regulatory science research to evaluate and treat cardiotoxicity of oncology therapeutics under opportunity number FOR-FD-25-015. The program reflects the FDA’s commitment to advancing regulatory science in oncology, with a particular focus on cardiotoxicity associated with cancer therapies. This initiative is designed to address gaps in understanding, monitoring, and treating cardiovascular side effects that arise in the development and use of oncology drugs, and the agency has signaled its intent to be directly involved in guiding the funded research. The primary purpose of this opportunity is to support research projects that generate practical, standardized approaches to evaluating cardiotoxicity in oncology therapeutics. Anticipated outputs include publications and presentations that inform regulatory decision-making. The FDA expects to play an active role in study design, provide feedback on interim deliverables, and conduct regular calls with investigators, rather than relying solely on annual reports. This collaboration is intended to ensure research outcomes align with regulatory needs and have broad translational potential for oncology trials and clinical practice. The scope of research is focused on several specific areas of interest. These include standardizing definitions for various types and grades of cardiotoxicity, developing consistent criteria for functional cardiac measures, and creating standardized monitoring plans for oncology trials. Additionally, applicants are encouraged to explore the use of biomarkers, imaging, and real-world data from electronic health records to strengthen the evaluation of cardiotoxicity. Projects may also focus on risk stratification models, patient-reported cardiovascular outcomes, collaborative data networks, and contributions to public databases. Beyond detection and monitoring, the FDA is interested in research to develop novel treatment strategies for cardiotoxicities and studies examining the natural history of these conditions in the context of cancer therapies. The program will be offered through a cooperative agreement funding instrument, ensuring that recipients work closely with FDA staff. The opportunity is classified under discretionary funding activities with a listed assistance number of 93.103, Food and Drug Administration Research. Although the total funding amount, award ceiling, and award floor have not yet been published, the agency has forecasted that two awards are expected. No cost-sharing or matching is required of applicants. Eligibility for this program is broad and includes state and local governments, Native American tribal governments and organizations, independent school districts, public housing authorities, public and private higher education institutions, nonprofits both with and without 501(c)(3) status, for-profit organizations other than small businesses, and small businesses. The eligibility structure indicates the opportunity is nationwide in scope, open to applicants in all U.S. states, territories, and tribal jurisdictions. As of now, the opportunity is in a forecasted status, with no official application open or close dates, award dates, or project start dates listed. The forecast posting date was November 20, 2024, and the agency has indicated Fiscal Year 2025 as the cycle for awards. Applicants should anticipate additional information to be released closer to the official posting date and should plan to monitor Grants.gov for updates. Since the program is likely to recur annually, organizations should consider preparing for future rounds even if deadlines are not yet published. For additional information, applicants may contact the listed grantor, Terrin Brown, at the Food and Drug Administration. Inquiries may be directed by phone at 240-402-7610 or via email at terrin.brown@fda.hhs.gov. Further details, including full application instructions, will be provided when the official funding announcement is posted.